isosorbide mononitrate
- Product NDC
- 43063-313
- 11-digit product format
- 430630313
- Labeler code
- 43063
- Product ID
- 43063-313_e6629504-b212-4cd1-e053-2a95a90a2826
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isosorbide mononitrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA075155
- Marketing category
- ANDA
- Marketing start
- 1998-10-30
- Marketing end
- 0000-00-00
- Substance
- ISOSORBIDE MONONITRATE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-313-30 | 43063031330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-313-30) | 2011-01-03 | 0000-00-00 | No | No | Current |